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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K261793

510(k) cleared

Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)

Maxter Healthcare, Inc. · Sep 9, 2026 · K261793

FDA cleared the Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) from Maxter Healthcare, Inc. on Sep 9, 2026 under K261793, a traditional 510(k). The device falls under product code LZA, Polymer Patient Examination Glove, regulated at 21 CFR 880.6250 as a Class 1 device. The review panel was General Hospital.

FDA logged the submission as received on May 29, 2026. The decision came 103 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Maxter Healthcare, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261793?

K261793 is the FDA 510(k) for Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color), submitted by Maxter Healthcare, Inc.. FDA's decision date was Sep 9, 2026, under product code LZA (Polymer Patient Examination Glove).

Who makes the Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)?

Maxter Healthcare, Inc., based in Rosharon, TX, is the applicant of record for K261793.

How long did the K261793 review take?

FDA received the submission on May 29, 2026 and issued its decision on Sep 9, 2026, 103 days later.

← All decisions in September 2026